enGen Track System with TCAutomation Software Version 4 — Class II medical device recall Z-0254-2018
Terminated recall by Ortho-Clinical Diagnostics, reported 2017-12-20, distributed in GA, IL, MO, NC, NY. A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient
| Recall number | Z-0254-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2017-04-26 |
| Classified | 2017-12-14 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2021-08-23 |
| Distributed | GA, IL, MO, NC, NY |
| Countries outside the US | CA, ES, FR, GB, IT |
| Quantity | 16 |
| Reason classes | software |
| Serial numbers | 3RHC23J, 5GV6W2J, 7KSC15J, 953252, CXL941J, JG7BFB5J |
Product
enGen Track System with TCAutomation Software Version 4.2
Reason for recall
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0254-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.